Phase II Clinical Trial of Bevacizumab (NSC 704865) and Low Dose Oral Cyclophosphamide in Recurrent Ovarian Cancer, Primary Peritoneal Carcinoma

Date de début de l'étude : 1 décembre 2003

Inclusion Criteria: * Histologically confirmed recurrent or metastatic ovarian epithelial or primary peritoneal cancer * Unidimensionally measurable disease * Previously irradiated indicator lesions must have progressed after radiotherapy * Received a platinum-containing regimen for primary disease * No more than 2 prior chemotherapy regimens for recurrent disease * Must have received prior platinum-based chemotherapy for recurrent disease if it has been \> 12 months since treatment for primary disease (except if hypersensitivity to platinum has developed) * Rechallenge with the same platinum-based regimen is considered 1 prior regimen * No history or clinical evidence of CNS disease, including primary brain tumor * No brain metastases * Performance status - SWOG 0-2 * At least 3 months * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * No bleeding diathesis * No coagulopathy * Bilirubin no greater than 1.5 times normal * ALT or AST no greater than 3 times upper limit of normal * INR less than 1.5 (for patients receiving warfarin) * Creatinine no greater than 1.5 times normal * No proteinuria (less than 1+) * Proteinuria less than 500 mg/24-hour urine collection * No prior deep vein thrombosis * No prior stroke * No clinically significant cardiovascular disease * None of the following within the past year: * Uncontrolled hypertension * New York Heart Association class II-IV congestive heart failure * Serious cardiac arrhythmia requiring medication * Grade II or greater peripheral vascular disease * None of the following within the past 6 months: * Unstable angina * Myocardial infarction * Transient ischemic attack * Cerebrovascular accident * Other arterial thromboembolic event * No clinically significant peripheral artery disease * No active infection requiring parenteral antibiotics * No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies * Not pregnant or nursing * Fertile patients must use effective contraception * No serious, non-healing wound, ulcer, or bone fracture * No significant traumatic injury within the past 28 days * No seizures not controlled with standard medical therapy * No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * All prior invasive malignancies must be in complete remission * No other concurrent medical, psychological, or social condition that would preclude study participation * No prior antiangiogenesis agents * See Disease Characteristics * Recovered from prior chemotherapy * See Disease Characteristics * Recovered from prior radiotherapy * More than 28 days since prior major surgical procedure or open biopsy and recovered * At least 3 weeks since prior therapy directed at the malignancy * No recent or concurrent full-dose anticoagulants or thrombolytic agents * Anticoagulants to maintain patency of preexisting, permanent indwelling IV catheters allowed * No concurrent chronic daily aspirin (greater than 325 mg/day) or nonsteroidal anti-inflammatory drugs known to inhibit platelet function